PMS-FINGOLIMOD

, Hepatic/Biliary/Pancreatic, Liver Function). • Pediatric patients (< 18 years of age): pms-FINGOLIMOD is not indicated for use in pediatric patients. 3 Pharmacokinetics, Special Populations and Conditions). 3 Pharmacokinetics, Special Populations and Conditions).

3 Pharmacokinetics, Special Populations and Conditions). 2 Clinical Trial Adverse Reactions, Macular Edema). Multiple sclerosis patients with concomitant diabetes mellitus were excluded from the clinical trials with fingolimod. 4. Administration • pms-FINGOLIMOD is taken orally, with or without food.

• Patients should be advised that pms-FINGOLIMOD remains in the blood and continues to have effects, including decreased blood lymphocyte counts, for up to 2 months following the last dose. First Dose Monitoring of Fingolimod Because initiation of pms-FINGOLIMOD treatment is associated with reversible heart rate decrease and atrioventricular (AV) conduction delays, patients must be closely monitored for cardiac effects during the administration of the first dose.

5 Missed Dose). pms-FINGOLIMOD (fingolimod) Page 9 of 65 Unclassified / Non classifié • For all patients, obtain an electrocardiogram (ECG) and measure blood pressure prior to and 6 hours after the first dose of fingolimod. • Monitor all patients for signs and symptoms of bradyarrhythmia, with hourly pulse and blood pressure measurements, for at least 6 hours after the first dose.

, continuous ECG monitoring) until the symptoms have resolved. , continuous ECG monitoring) in a medical facility should be instituted and the first dose monitoring strategy should be repeated when the second dose of fingolimod is administered.

Extended monitoring, until the finding has resolved, is also required: • if the heart rate at 6 hours post-dose is <45 bpm, or is the lowest value post-dose, or • if the ECG at 6 hours after the first dose shows new-onset second-degree or higher grade AV block.

• If the ECG at 6 hours after the first dose shows a QTc interval ≥500 msec, patients should be monitored overnight. Patients should be advised that the ability to drive an automobile or operate dangerous equipment may be impaired during the first day of treatment.

See 7 Warnings and Precautions, Monitoring and Laboratory Tests for recommendations regarding monitoring that should be performed during therapy with pms-FINGOLIMOD. 5. Missed Dose If a dose is missed, treatment should be continued with the next dose as planned.

, monitor for at least 6 hours after the first dose) if fingolimod therapy is discontinued: • For one day or more within the first 2 weeks of treatment • For more than 7 days during weeks 3 and 4 of treatment • For more than 2 weeks, after the first month of treatment 5.

5mg) were well tolerated in healthy adult volunteers. Fingolimod doses of 5 mg to 40 mg were associated with a mild to moderate, dose dependent decrease in FEV1. At 40 mg, 5 of 6 subjects reported mild chest tightness or discomfort which was clinically consistent with small airway reactivity.